EMA approves AI tool for biopsy analysis in liver disease trials

Artificial intelligence (AI) technology can be used to support the analysis of biopsies in liver disease-focused clinical trials, according to the European Medicines Agency (EMA).

The EMA’s Committee for Medicinal Products for Human Use (CHMP) gave AI the green light last month when it recommended the approval of an AI analysis tool developed by US digital pathology firm PathAI.

It wrote, “CHMP considers that the proposed AI-based Measurement of Non-alcoholic Steatohepatitis Histology (AIM-NASH) tool can be used in metabolic dysfunction associated steatohepatitis (MASH) clinical trials as an aid to trial pathologists.”

The committee added, “The method can be used for all MASH clinical trials in which the histologic evaluation of liver tissue is used as part of the inclusion criteria, and/or efficacy evaluation.”

The EMA reviewers contrasted the approach with traditional biopsy assessment methods and concluded that using AI would aid consistency.

“The current method by which pathologists apply NASH histologic scoring systems is subjective and prone to variability, whereas the machine learning-assisted approach is expected to be more accurate and, most importantly, more reproducible.

“Therefore, AIM-NASH has the potential to be used to aid clinical trial enrollment and histologic endpoint assessment, providing value for accelerated and traditional NASH drug approval pathways,” the EMA authors wrote.

Clinical innovation

PathAI’s technology is designed to track a disease activity biomarker, aiming to help a human pathologist decide whether patients meet inclusion criteria for Phase II and III studies.

The Boston, Massachusetts-based firm welcomed the recommendation, with a spokesman telling Clinical Insider, “AIM-MASH AI Assist is available for use in any Phase II or III clinical trial via deployment on PathAI’s GCP compliant and validated AISight Clinical Trials Platform.

“Sponsors can work directly with PathAI or contract through the many CROs that PathAI has established strong relationships with to facilitate the incorporation of AIM-MASH AI Assist into MASH clinical trials,” he said.

PathAI claims it has relationships with 90% of the top 15 biopharma companies, which are leveraging its AI to transform how pathology is used in clinical development.

The spokesman said, “AI-based tools are already being utilized to make clinical trials more efficient by making patient enrolment and analysis of data faster and by improving the accuracy and reproducibility of results,” citing pre-screening as an example.

“AI-based tools are also supporting the discovery of new biomarkers to be used to inform clinical development pipelines and commercialization of new treatments,” he added.

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Unsplash/Mohamed Nohassi